Description:

Recurrent pericarditis is one of the most common and troublesome complications of acute pericarditis, occurring in 10-50% of patients with pericarditis. Colchicine has been shown to be promising for the secondary prevention of recurrent pericarditis in the CORE (recurrent pericarditis) and COPE (acute pericarditis) open-label studies. The current trial sought to compare the safety and efficacy of colchicine compared with placebo, in addition to standard therapy, in patients with recurrent pericarditis, in a double-blind randomized controlled fashion.

Hypothesis:

Colchicine would be superior to placebo in reducing recurrent pericarditis in patients with a first episode of recurrent pericarditis.

Study Design

Placebo Controlled

Blinded

Randomized

Parallel

Patient Populations:

Definite diagnosis of recurrent pericarditis (first recurrence), defined as previous history of acute pericardits with recurrent chest pain and one or more of the following signs: (a) fever, (b) pericardial friction rubs, (c) electrocardiographic changes, (d) echocardiographic evidence of new or worsening pericardial effusion, and (e) elevations in the white blood cell count, erythrocyte sedimentation rate, or C-reactive protein

Concomitant Medications:

Principal Findings:

A total of 120 patients were randomized, 60 to colchicine and 60 to placebo. Baseline characteristics were fairly similar between the two arms. The majority of patients (82%) had idiopathic pericarditis; about 18% had a possible autoimmune cause. About 6% had undergone prior cardiac surgery, 11% prior myocardial infarction, and 9% had been treated with corticosteroids before.

At 18 months, recurrence rate was 24% in the colchicine group versus 55% in the placebo group (relative risk [RR] 0.44, 95% confidence interval [CI] 0.27-0.73, p < 0.001). This corresponded to a number needed to treat of three patients. Colchicine also significantly reduced the persistence of symptoms at 72 hours (23% vs. 53%, RR 0.46, 95% CI 0.26-0.73, p = 0.001), and the mean number of recurrences (0.1 vs. 1, p < 0.001). At the same time, colchicine increased the remission rate at 1 week (82% vs. 48%, p < 0.001), and prolonged the time to a subsequent recurrence (2.5 vs. 1 months, p < 0.001). No differences were noted in the incidence of readmission or cardiac tamponade; no cases of constrictive pericarditis were recorded in either arm.

Interpretation:

The results of this trial indicate that low-dose colchicine, in addition to empiric anti-inflammatory therapy, may be safe and efficacious in reducing rates of recurrent pericarditis in patients with mostly idiopathic recurrent pericarditis. It also improves remission rates and hastens symptom resolution. These are interesting findings and extend earlier findings by the same investigators with colchicine.

Although infrequent, recurrent pericarditis can be quite troublesome, and sometime debilitating; treatment options thus far have been limited either by efficacy or side effects. Colchicine may prove to be a valuable addition to the treatment armamentarium for recurrent pericarditis. Further studies will need to outline whether it can be used as a solitary agent, and whether it has any role in preventing pericarditis in patients at high-risk, such as those undergoing pericardiotomy.